drugset / Trial / NCT06189157
MB-CART19.1 in Refractory SLE
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus. In the phase I part, a maximum of n=12 patients will be treated in a maximum of 3 dose levels. In the phase IIa part, a maximum of n=17 will be treated (n=10 patients in a 1st stage + n=7 patients in a 2nd stage). This includes the patients from the phase I part treated on the recommended dose level.
Timeline
- Start
- 2024-08-12
- Primary completion
- 2027-09-30
- Completion
- 2027-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anti-CD19 CAR-T cells | Cell therapy | 100000 cells | — |
| Subject | anti-CD19 CAR-T cells | Cell therapy | 500000 cells | — |
| Subject | anti-CD19 CAR-T cells | Cell therapy | 1e+06 cells | — |